C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS › Subpart A—General Provisions

21 C.F.R. § 812.3

Definitions

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(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended (21 U.S.C. 301-392)).

(b) A custom device means a device within the meaning of section 520(b) of the Federal Food, Drug, and Cosmetic Act.

(c) FDA means the Food and Drug Administration.

(d) Implant means a device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. FDA may, in order to protect public health, determine that devices placed in subjects for shorter periods are also “implants” for purposes of this part.

(e) Institution means a person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans. The term includes, for example, a hospital, retirement home, confinement facility, academic establishment, and device manufacturer. The term has the same meaning as “facility” in section 520(g) of the act.

(f) Institutional review board (IRB) means any board, committee, or other group formally designated by an institution to review biomedical research involving subjects and established, operated, and functioning in conformance with part 56. The term has the same meaning as “institutional review committee” in section 520(g) of the act.

(g) Investigational device means a device, including a transitional device, that is the object of an investigation.

(h) Investigation means a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device.

(i) Investigator means an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.

(j) Monitor, when used as a noun, means an individual designated by a sponsor or contract research organization to oversee the progress of an investigation. The monitor may be an employee of a sponsor or a consultant to the sponsor, or an employee of or consultant to a contract research organization. Monitor, when used as a verb, means to oversee an investigation.

(k) Noninvasive, when applied to a diagnostic device or procedure, means one that does not by design or intention: (1) Penetrate or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra, or (2) enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical os. For purposes of this part, blood sampling that involves simple venipuncture is considered noninvasive, and the use of surplus samples of body fluids or tissues that are left over from samples taken for noninvestigational purposes is also considered noninvasive.

(l) Person includes any individual, partnership, corporation, association, scientific or academic establishment, Government agency or organizational unit of a Government agency, and any other legal entity.

(m) Significant risk device means an investigational device that:

(1) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;

(2) Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;

(3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or

(4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

(n) Sponsor means a person who initiates, but who does not actually conduct, the investigation, that is, the investigational device is administered, dispensed, or used under the immediate direction of another individual. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators.

(o) Sponsor-investigator means an individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. The term does not include any person other than an individual. The obligations of a sponsor-investigator under this part include those of an investigator and those of a sponsor.

(p) Subject means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease.

(q) Termination means a discontinuance, by sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion.

(r) Transitional device means a device subject to section 520(l) of the act, that is, a device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976.

(s) Unanticipated adverse device effect means any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

(t) Independent ethics committee (IEC) means an independent review panel that is responsible for ensuring the protection of the rights, safety, and well-being of subjects involved in a clinical investigation and is adequately constituted to ensure that protection. An institutional review board (IRB), as defined in paragraph (f) of this section and subject to the requirements of part 56 of this chapter, is one type of IEC.

[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 48 FR 15622, Apr. 12, 1983; 81 FR 70340, Oct. 12, 2016; 83 FR 7385, Feb. 21, 2018; 83 FR 7385, Feb. 21, 2018]
Notes of Decisions
Cited in 10 cases (1 in the last 5 years), 1995–2023 · leading case: United States v. Endotec, Inc., 563 F.3d 1187 (11th Cir. 2009).
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United States v. Endotec, Inc., 563 F.3d 1187 (11th Cir. 2009). · cites it 4× “Stated differently, 21 C.F.R. § 812.3 tracks the statutory language for the most part but breaks down the custom device requirements into a list format: Custom device means a device that: (1) Necessarily deviates from devices generally available or from an applicable performance…”
Femrite v. Abbott Nw. Hosp., 568 N.W.2d 535 (Minn. Ct. App. 1997). · cites it 4× “" 21 C.F.R. § 812.3 (h) (1996). A hospital may not initiate investigational studies under an IDE without approval and oversight by a hospital's institutional review board (IRB).”
Byrd v. Janssen Pharm., Inc., 333 F. Supp. 3d 111 (N.D.N.Y. 2018). · cites it 2× “) See 21 C.F.R. § 812.3 (i) ("Investigator means an individual who actually conducts a clinical investigation, i.”
prod.liab.rep. (Cch) P 14,260 Lora Lohr, Michael Lohr, Her Husband v. Medtronic, Inc., a Foreign Corp., 56 F.3d 1335 (11th Cir. 1995). “21 C.F.R. § 812.3 (g). See 21 U.S.C.A. § 360j(g).”
Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71 (2d Cir. 2006). · cites it 2× “, “any board, committee, or other group formally designated by an institution to review biomedical research involving subjects,” 21 C.F.R. 812.3(f) — which must determine that the “[rjisks to subjects are reasonable in relation to anticipated benefits,” 21 C.”
Nexell Therapeutics, Inc. v. Amcell Corp., 143 F. Supp. 2d 407 (D. Del. 2001). “See 21 C.F.R. § 812.3 . This type of trial is in contrast to a company-sponsored trial in which the company develops the protocol and requires the investigator to follow the company’s plan.”
Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71 (2d Cir. 2006). · cites it 2× “, "any board, committee, or other group formally designated by an institution to review biomedical research involving subjects," 21 C.”
Briggs v. Endologix, Inc. (S.D. Tex. 2023). “” 21 C.F.R. § 812.3 (n). D. PLAINTIFFS SHOULD NOT BE PERMITTED TO AMEND THEIR COMPLAINT Plaintiffs originally filed this lawsuit in state court.”
East Texas Med. Ctr. Gilmer v. Birder Porter (Tex. App. 2015). “Implantable device: according to FDA, "device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more" [21 CFR 812.3(d)]. Inanimate surface: nonliving surface (e.”
Lohr v. Medtronic, Inc. (11th Cir. 1995). “21 C.F.R. § 812.3 (g). See 21 U.S.C.A. § 360j(g).”
— 21 C.F.R. § 812.3(d) — 1 case
East Texas Med. Ctr. Gilmer v. Birder Porter (Tex. App. 2015). “Implantable device: according to FDA, "device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more" [21 CFR 812.3(d)]. Inanimate surface: nonliving surface (e.”
— 21 C.F.R. § 812.3(f) — 2 cases
Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71 (2d Cir. 2006). “, “any board, committee, or other group formally designated by an institution to review biomedical research involving subjects,” 21 C.F.R. 812.3(f) — which must determine that the “[rjisks to subjects are reasonable in relation to anticipated benefits,” 21 C.”
Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71 (2d Cir. 2006). “, "any board, committee, or other group formally designated by an institution to review biomedical research involving subjects," 21 C.”
— 21 C.F.R. § 812.3(m) — 2 cases
Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71 (2d Cir. 2006). “, “any board, committee, or other group formally designated by an institution to review biomedical research involving subjects,” 21 C.F.R. 812.3(f) — which must determine that the “[rjisks to subjects are reasonable in relation to anticipated benefits,” 21 C.”
Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71 (2d Cir. 2006). “, "any board, committee, or other group formally designated by an institution to review biomedical research involving subjects," 21 C.”
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